Magna Mitral - 23mm

Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01312779

Enrollment

Registered

2011-03-11

Start date

2011-03-31

Completion date

2018-11-30

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Heart Valve Disease

Keywords

Mitral Valve Replacement, 23mm CEP, Magna

Brief summary

The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.

Detailed description

This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.

Interventions

DEVICEImplantation of CEP Magna Mitral Model 7000TFX

Heart valve surgery: CEP Magna Mitral Model 7000 TFX

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient has mitral valve disease requiring surgical replacement 2. Patient has provided written informed consent prior to mitral valve surgery 3. Patient is expected to survive surgery and be discharged 4. Patient is willing to comply with specified follow-up evaluations 5. Patient is 13 years of age or older

Exclusion criteria

1. Patient has life expectancy \< 12 months due to non-cardiac co-morbid conditions; 2. Patient has/had active endocarditis within the last 3 months 3. Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve; 4. Patient was previously enrolled and implanted in the study 5. Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ 6. Patient has a body surface area (BSA) \> 1.9m2 7. Female patients who are pregnant, planning to become pregnant, or lactating 8. Patient has a documented history of substance ( drug or alcohol) abuse 9. Patient is currently a prison inmate 10. Patient is currently participating in an investigational drug or another device study 11. Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism 12. Patient has active myocarditis 13. Patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized \> 30 days prior to the planned v alve implant surgery 14. Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might place

Design outcomes

Primary

Measure	Time frame	Description
Percent of Early Adverse Events Divided	Events occuring within 30 days of procedure	Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Percent of Late Adverse Events	Events occurring >= 31 days and up through 5 years post-implant	Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	>30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Subject's Average Effective Orifice Area (EOA) Measurement	Pre-procedure and 1 Year post-Implant	Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.

Other

Measure	Time frame	Description
Subject's Average Cardiac Output	Pre-procedure and 1 Year post-implant	The amount of blood the heart pumps through the circulatory system in a minute.
Subject's Average Cardiac Index	Pre-procedure and 1 Year post-implant	Cardiac index is an assessment that divides the cardiac output from the left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.
Subject's Average Left Ventricular Mass Regression	Pre-procedure and 1 Year post-implant	Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve.
Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant.	1 Year post-implant	Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Subject's Average Red Blood Cells Count	Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
Subject's Average White Blood Cell Count	Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Laboratory analysis of White Blood Cell (WBC) Count on blood drawn from subject; WBC fight infection.
Subject's Average Mean Gradient Measurement	Pre-procedure and 1 Year post-implant	Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Subject's Average Plasma Free Hemoglobin	Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).
Subject's Average Hemoglobin Count	Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Subject's Average Platelet Count	Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant.	Baseline and 1 Year post-implant	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline	6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time	6 Months and 1 Year post-implant	The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Subject's Average Hematocrit Percentage	Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).
Subject's Average Peak Gradient Measurement	Pre-procedure and 1 Year post-implant	Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Subject's Average Effective Orifice Area Index (EOAI) Measurement	Pre-procedure and 1 Year post-implant	Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Subject's Average Performance Index Measurement	Pre-procedure and 1 Year post-Implant	Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

Countries

Poland, United States

Participant flow

Participants by arm

Arm	Count
Magna Mitral 23 Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	12
Total	12

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	3
Overall Study	Not Implanted with Device	27
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Magna Mitral 23	—
Age, Continuous	67.5 years STANDARD_DEVIATION 14	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	12 Participants	—
Sex: Female, Male Male	0 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 12
other Total, other adverse events	11 / 12
serious Total, serious adverse events	12 / 12

Outcome results

Primary

Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days

Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method.

Time frame: >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant